Multiple Ascending Doses of MEDI6012 in Subjects With Stable Atherosclerotic Cardiovascular Disease
NCT ID: NCT03004638
Last Updated: 2018-12-19
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
32 participants
INTERVENTIONAL
2017-01-23
2017-11-02
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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MEDI6012 40 mg
Participants received 3 doses of 40 milligram (mg) MEDI6012 IV on Days 1, 8, and 15.
MEDI6012 40 mg
Participants received 3 doses of 40 milligram (mg) MEDI6012 IV on Days 1, 8, and 15.
Placebo
Participants received 3 doses of placebo matching with MEDI6012 intravenously (IV) on Days 1, 8, and 15.
Placebo
Participants received 3 doses of placebo matching with MEDI6012 intravenously (IV) on Days 1, 8, and 15.
MEDI6012 120 mg
Participants received 3 doses of 120 mg MEDI6012 IV on Days 1, 8, and 15.
MEDI6012 120 mg
Participants received 3 doses of 120 mg MEDI6012 IV on Days 1, 8, and 15.
MEDI6012 300 mg
Participants received 3 doses of 300 mg MEDI6012 IV on Days 1, 8, and 15.
MEDI6012 300 mg
Participants received 3 doses of 300 mg MEDI6012 IV on Days 1, 8, and 15.
MEDI6012 IV Push
Participants received 3 doses of MEDI6012 by IV push as 300 mg loading dose on Day 1, and maintenance doses of 150 mg and 100 mg on Day 3 and Day 10, respectively.
MEDI6012 IV Push
Participants received 3 doses of MEDI6012 by IV push as 300 mg loading dose on Day 1, and maintenance doses of 150 mg and 100 mg on Day 3 and Day 10, respectively.
Placebo IV Push
Participants received 3 doses of placebo matching with MEDI6012 by IV push. A loading dose on Day 1 and maintenance doses on Days 3 and 10.
Placebo IV Push
Participants received 3 doses of placebo matching with MEDI6012 by IV push. A loading dose on Day 1 and maintenance doses on Days 3 and 10.
Interventions
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MEDI6012 40 mg
Participants received 3 doses of 40 milligram (mg) MEDI6012 IV on Days 1, 8, and 15.
Placebo
Participants received 3 doses of placebo matching with MEDI6012 intravenously (IV) on Days 1, 8, and 15.
MEDI6012 120 mg
Participants received 3 doses of 120 mg MEDI6012 IV on Days 1, 8, and 15.
MEDI6012 300 mg
Participants received 3 doses of 300 mg MEDI6012 IV on Days 1, 8, and 15.
Placebo IV Push
Participants received 3 doses of placebo matching with MEDI6012 by IV push. A loading dose on Day 1 and maintenance doses on Days 3 and 10.
MEDI6012 IV Push
Participants received 3 doses of MEDI6012 by IV push as 300 mg loading dose on Day 1, and maintenance doses of 150 mg and 100 mg on Day 3 and Day 10, respectively.
Eligibility Criteria
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Inclusion Criteria
* Diagnosis of stable atherosclerotic CVD
* Currently receiving a stable dose of Statin
Exclusion Criteria
* Elective arterial revascularization with in the past month
* Any planned arterial revascularization
* Body mass index \<18 or \>45
* Clinically significant ECG that may interfere with the interpretation of serial ECG and QT interval changes at screening
* Chronic kidney disease defined by estimated glomerular filtration rate of less than 30 mL/mim/1.73m2
* Triglycerides greater than 500 mg/dL, LDL-C greater than 160 mg/dL, or HDL-C greater than 60 for males, or 65 for females
* Clinically significant vital sign abnormalities
* Genetic disorder of cholesterol metabolism
* History of overt liver disease
* Poorly controlled endocrine disorder (Diabetes or Thyroid disorder)
* Current or recent use of systemic corticosteroids
* Recent or ongoing infection or febrile illness
* History of active malignancy within 5 years
* History of alcohol or recreational substance abuse in the past 6 months
* Concurrent enrollment in another clinical study of any investigational drug therapy or use of any biologicals within 6 months prior to screening or within 5 half-lives of an investigational agent or biologic, whichever is longer.
60 Years
80 Years
ALL
No
Sponsors
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MedImmune LLC
INDUSTRY
Responsible Party
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Locations
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Research Site
Anniston, Alabama, United States
Research Site
Jacksonville, Florida, United States
Research Site
Port Orange, Florida, United States
Research Site
Cincinnati, Ohio, United States
Countries
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Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Related Links
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D5780C00005-CSP-amendment-1\_REDACTED\_16Jul2017\_PDF-A
5780C00005 MEDI6012 Statistical Analysis Plan\_21Jul2017\_Version2\_Redacted\_PDF-A.pdf
Other Identifiers
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D5780C00005
Identifier Type: -
Identifier Source: org_study_id